During an inspection of your firm located in Miamisburg, Ohio, on January 5, 2009 through February 2, 2009, and also at your firm located in Piqua, Ohio on January 8, 2009, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures breast pumps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. The investigators determined that while these manufacturing sites are located in different cities, they are actually part of one business enterprise and operate under the same management control.

This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act (21 U.S.C. § 351 (h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practices (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your five responses dated, March 17, 2009, April 13, 2009, May 7, 2009, June 12, 2009, and July 16, 2009, concerning our investigators' observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address these responses below, in relation to each of the noted violations. With the exception of item number 2 below, the violations were all observed at the Miamisburg facility. The violations described in item number 2 were observed at both the Piqua and Miamisburg locations. These violations include, but are not limited to, the following:

1. Failure to verify or validate corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).

For example:

• You amended your document control procedure to address documents generated by external sources but failed to validate this change (see CAR-08-0003).
• To correct low suction in the pumps and locking tab breakage (see CAR-08-0007), you added a rib to the horn release button but failed to validate this action.
• Based on complaint analysis, you added a rib to the overflow valve to prevent milk from overflowing and causing problems with the pump (ECN# 080213-5948) but failed to validate this action.

We have reviewed your responses and have concluded that they are only partially adequate. You revised your CAPA procedure and verified the corrective actions for CAR-08-007 and ECN# 080213-5948. However, your corrective actions did not extend to the Comfort Select devices which you sold prior to December 2008, and your verification of your corrective actions failed to justify such.

2. Failure to review and evaluate all complaints to determine whether an investigation is necessary and where no investigation is made, failure to maintain a record that includes the reason no investigation was made, and failure to investigate all complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(b) and (c).

For example: Out of thirty-seven complaints reviewed by the FDA investigators, eighteen complaints were not investigated by your firm, and there were no documented reasons for not performing the investigations. Specific examples include:

• Incident 24111, dated September 25, 2007: alleged milk came out of the electrical adapter port and caused an electrical shock in the breast and hand.
• Incident 24590, dated November 12, 2007: alleged the consumer was shocked while plugging the unit into a wall.
• Incident 24783, dated December 11, 2007: alleged the consumer felt a shock when using the pump, milk came out of the motor housing, as well as vacuum variation.

Your response to this observation appears to be adequate.

3. Failure to establish and maintain procedures to control the design of a device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

For example: the Comfort Select Performance Single and Dual Pumps were released for production on October 16, 2008; however, the drawings were not approved for release by all parties until January 8, 2009.

Your response to this observation appears to be adequate.

4. Failure to establish and maintain procedures for validating the device design, including documentation of risk analysis, where appropriate, as required by 21 CFR 820.30(g).

For example: you conducted design meetings on March 27, 2008, May 13, 2008, and September 25, 2008, but you failed to adequately document the content of those meetings, including content on the methods you used to conduct risk analysis.

Your response to this observation appears to be adequate.

5. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, and to document such audits, as required by 21 CFR 820.22.

For example: Your firm claimed that an internal audit or quality audit was conducted in October 2008 on the Corrective and Preventive Action system. However, the documentation for the internal audit of the CAPA system could not be found.

We have reviewed your response to this observation and determined that its adequacy cannot be determined at this time. You stated that the audit had not been performed and that there was a documentation error. You have supplied modified written procedures with your response letters. However, it is unclear to us how these changes to the procedure will prevent you from failing to perform future audits. Please explain how these changes to the procedure will prevent you from failing to conduct an audit in the future. During the next inspection, FDA will verify that your firm has conducted audits and documented them in accordance with approved procedures.

Our inspection also revealed that your firm failed to establish Medical Device Reporting (MDR) procedures for your breast pumps, as required by 21 CFR 803.17. This violation includes, but is not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.

We have reviewed your responses and have concluded that they are inadequate because you have not developed MDR procedures that will provide for timely and effective identification, communication, and evaluation of events that may be subject to the MDR requirements. Further, the procedures do not describe a process for determining when an event meets the criteria for reporting, how your firm will meet the regulatory timeframes to ensure timely transmission of complete MDRs, or how your firm will document information and keep records.

For example your procedures do not describe how you will:

a. Submit initial, supplemental, or 5-day reports to the FDA within the timeframes required by 21 CFR 803.50, 803.53 and 803.56;
b. Conduct an investigation of each event, evaluate the cause of the event, and submit complete reports to FDA, as required by 21 CFR 803.50(b)(3);
c. Provide all information reasonably known to you as required by 21 CFR 803.50(b)(1);
d. Include all of the information in your reports that is required by 21 CFR 803.52.

Our inspection also revealed that, in May 2008, prior to obtaining FDA clearance of the Comfort Select Performance breast pump (K082307, cleared September 2008), you conducted a clinical investigation on this device. Even though FDA would consider this to be a non-significant risk device, because you did not comply with the abbreviated requirements at 21 CFR 812.2(b)(1) (for example you failed to obtain Institutional Review Board (IRB) review and approval of your investigation and failed to ensure informed consent was obtained from each subject under 21 CFR part 50) you were not considered to have an approved application for an Investigational Device Exemption (IDE). Therefore, you violated both 21 CFR 56.103(a) (requiring IRB approval of an investigation) and 21 CFR 812.42 (requiring both FDA and IRB approval of an investigation).

We have reviewed your response and have concluded it is inadequate. You claim that the study was not for the purpose of determining safety or effectiveness and therefore exempt from IRB review and approval requirements under 21 CFR 812.2(c)(4). However, as stated in the (b)(4). Since one of the purposes of your study was to determine the effectiveness of the modified pump, your study was not exempt under 21 CFR 812.2(c)(4).

In addition, you suggest that a new 510(k) was not required for the Comfort Select Performance pump and state that you filed the new 510(k) for the modified device in an abundance of caution. However, since the modifications, such as those related to (b)(4) could significantly affect the safety or effectiveness of the device, a new 510(k) was required for a modified device under 21 CFR 807.81 (a)(3)(i).

You also explain that you have conducted training and established procedures to identify clinical investigations requiring IRE and/or FDA approval and informed consent. We have concluded your response is inadequate because you have not developed procedures that will ensure compliance with all of the requirements of2l CFR 812.2(b)(1) for future studies involving human research subjects. Please provide corrective actions describing how you will ensure future studies comply with all of the requirements of 21 CFR 812.2(b)(1).

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Stephen J. Rabe, Compliance Officer. If you have any questions about the content of this letter please contact: Mr. Rabe at 513-679-2700 ext 163 or FAX 513-679-2775.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facilities. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.